Phoenix Dental, Inc.: FDA clearances and approvals
Phoenix Dental, Inc. has 5 FDA 510(k) clearances (first 1994, latest 2012), across 4 product codes in 1 review panel. Median 510(k) review time: 164 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 54 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 2 | 2 |
| EJK | Liner, Cavity, Calcium Hydroxide | 1 | 1 |
| LBH | Varnish, Cavity | 1 | 1 |
| LFC | Device, Caries Detection | 1 | 1 |
Review panels
- Dental (5)
Most recent Phoenix Dental, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120109 | SUPER SEAL TOOTH DESENSITIZER | LBH | 2012-03-07 | 54 |
| K102821 | DISCOVRED | LFC | 2011-03-11 | 164 |
| K983477 | SUPER SEAL | EJK | 1998-12-22 | 81 |
| K926101 | PHOENIX OPTI-MAX DENT IMPL W/PLAS-SPRAY TITA/HYDRO | DZE | 1994-06-23 | 567 |
| K926102 | PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN | DZE | 1994-06-22 | 566 |
Recalls
openFDA lists no recalls under a recalling firm named Phoenix Dental, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Phoenix Dental, Inc. have?
Phoenix Dental, Inc. has 5 FDA 510(k) clearances (first 1994, latest 2012), across 4 product codes in 1 review panel.
How long does FDA take to clear Phoenix Dental, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Phoenix Dental, Inc.'s cleared 510(k)s is 164 days.
What devices does Phoenix Dental, Inc. make?
Its most frequent FDA product codes are DZE (Implant, Endosseous, Root-Form, 2); EJK (Liner, Cavity, Calcium Hydroxide, 1); LBH (Varnish, Cavity, 1).
Has Phoenix Dental, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Phoenix Dental, Inc. Related entities may recall under other names.
Next steps
- See all 5 Phoenix Dental, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Phoenix Dental, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.